Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Randomized Study of Docetaxel, Doxorubicin, and Cyclophosphamide in Women With Advanced Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 to 69	NCI, Pharmaceutical / Industry	CWRU-040314 CWRU-AVEN-1103, AVENTIS-XRP6976D/1001, NCT00074139

Trial Description

Purpose:

Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them at different times, may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.

Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer.

Eligibility:

• 18-69 years old
• No brain metastases or leptomeningeal metastases
• At least 6 months since paclitaxel or docetaxel
• More than 2 weeks since surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will receive infusions of doxorubicin and cyclophosphamide on days 1 and 22. On day 22, they will also receive a 1-hour infusion of docetaxel.

Patients in group two will receive a 1-hour infusion of docetaxel on day 1. They will also receive infusions of doxorubicin and cyclophosphamide on days 1 and 22.

Treatment in both groups may continue for as long as benefit is shown. Patients will be evaluated every 3-4 weeks.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Beth Overmoyer, MD, FACP, Principal investigator		Ph: 216-844-8573 Email: bao4@po.cwru.edu

Registry Information
Official Title		A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/m2 IV On The Combination Therapy Doxorubicin (50 mg/m2) And Cyclophosphamide (50 mg/m2) In The Treatment Of Advanced Breast Cancer
Trial Start Date		2003-09-22
Registered in ClinicalTrials.gov		NCT00074139
Date Submitted to PDQ		2003-10-23
Information Last Verified		2004-07-26
NCI Grant/Contract Number		P30-CA43703

Back to Top